Effect of Statins on Asthma Control in Smokers With Asthma

NCT00463827 | Completed Phase 2 DMC

• 1 other identifier: AR 003
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a chronic inflammatory condition of the lungs. There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers. Statins are drugs which are already used to lower cholesterol. They have also been shown to have some anti-inflammatory properties. In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet. The investigators will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.

Conditions

Asthma; COPD; Smoking

Keywords

asthma; smokers; statin; atorvastatin; randomised; placebo; cigarette; blind; COPD

Outcome Measures

Primary Outcomes (1)

• Change in peak flow data

  4 weeks

Secondary Outcomes (10)

• sputum cell counts

  4 weeks and 8 weeks

• spirometry

  4 weeks and 8 weeks

• airway responsiveness to methacholine

  4 weeks and 8 weeks

• symptom scores

  4 weeks and 8 weeks

• Exhaled and alveolar NO

  4 weeks and 8 weeks

Study Arms (2)

2

ACTIVE COMPARATOR

Atorvastatin 40

Drug: Atorvastatin

placebo

PLACEBO COMPARATOR

matched placebo

Drug: matched placebo

Interventions

atorvastatin DRUG

2

matched placebo DRUG

Matched placebo

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of asthma for more than 1 year
• Symptomatic asthma
• Smoker with greater than 5 pack year history
• On short acting bronchodilator only- although may have medication weaned if stable

You may not qualify if:

• Ex-smokers or non-smokers
• Patients already on statin therapy
• Unstable asthma
• Previous statin sensitivity or myopathy or myositis
• On any medications known to interact with statins
• Note separate entry criteria for pilot study of COPD patients

Sponsors & Collaborators

• NHS Greater Clyde and Glasgow: lead
• University of Glasgow: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Related Publications (1)

• Braganza G, Chaudhuri R, McSharry C, Weir CJ, Donnelly I, Jolly L, Lafferty J, Lloyd SM, Spears M, Mair F, Thomson NC. Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial. BMC Pulm Med. 2011 Apr 7;11:16. doi: 10.1186/1471-2466-11-16.

  PMID: 21473764 DERIVED

Related Links

• Unit website

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Smoking

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Neil Thomson, FRCP

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)